The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy

Post Operative Pain Clinical Trial

Official title:

The Effect of Local Infiltration Technique on Postoperative Pain After Adult Tonsillectomy: A Randomized Double-blind Clinical Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03806335
• Other study ID #: 32015
• Status: Suspended
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: January 2023

Study information

• Verified date: January 2022
• Source: Makassed General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tonsillectomy is commonly associated with postoperative pain. The modified pre-incision infiltration of anesthetic mixture combined with general anesthesia was shown to decrease post-tonsillectomy pain in children. Hence, the present clinical trial will assess the effectiveness of this technique in adults undergoing tonsillectomy.

Description:

The study will be conducted prospectively, using a randomized double-blind design. Adult patients scheduled for total or partial tonsillectomy with or without adenoidectomy starting from January 2019 till January 2020 will be included.Patients will be allocated randomly into two equal groups using the sealed envelope method. Both groups will receive general anesthesia. Then, one group will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil. The second group will have placebo infiltration.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with total or partial tonsillectomy with or without adenoidectomy

Exclusion Criteria:

• patients who took antiemetics, steroids, or antihistaminics within 24 hours before surgery. - patients who have asthma
• patients who have diabetes
• patients who have bleeding problems
• patients who are suspected to have signs of acute pharyngeal infection

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Other:
• Infiltration
The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 2.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 10 ml xylocaine 2% an d10 ml bupivacaine 0.5%
• Placebo
Patients will receive 2.5 ml normal saline in each tonsil
• General anesthesia
All patients will receive general anesthesia prior to infiltration

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain	Pain after the operation will be assessed using the Visual Analogue Scale (VAS). A minimum VAS score is 0 and the maximum score is 10.	within 10 days after the operation
Secondary	PONV	Post operative nausea and vomiting (PONV) will be assessed through a questionnaire	within 10 days after the operation